Company: Tandem Diabetes Care, Inc.
Date of Enforcement Report: 4/11/2025
Class I
PRODUCT
t:slim X2 Insulin Pump with Interoperable Technology
Recall Number:
Z-1519-2025
REASON:
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
RECALLING FIRM/MANUFACTURER:
Tandem Diabetes Care, Inc.
VOLUME:
63 units
DISTRIBUTION:
US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
